BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3140506 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-04473
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    August 17, 2011
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTP
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT'S ATTORNEY, AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM (MFR REPORT #3005099803-2013-03785) AND AN UPHOLD VAGINAL SUPPORT SYSTEM (MFR REPORT #3005099803-2013-04473) WERE IMPLANTED INTO THE PATIENT ON (B)(4) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240835 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC CORPORATION M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other